TARO-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
19-10-2022
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Ingredient activ:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)
Disponibil de la:
TARO PHARMACEUTICALS INC
Codul ATC:
N06AX23
INN (nume internaţional):
DESVENLAFAXINE
Dozare:
50MG
Forma farmaceutică:
TABLET (EXTENDED-RELEASE)
Compoziție:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 50MG
Calea de administrare:
ORAL
Unități în pachet:
15G/50G
Tip de prescriptie medicala:
Prescription
Rezumat produs:
Active ingredient group (AIG) number: 0152509001; AHFS:
Statutul autorizaţiei:
APPROVED
Data de autorizare:
2022-10-20
Caracteristicilor produsului
PRODUCT MONOGRAPH
PR TARO-DESVENLAFAXINE
desvenlafaxine extended-release tablets
50 mg and 100 mg desvenlafaxine (as desvenlafaxine succinate
monohydrate
)
Antidepressant
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive
OCT 19, 2022
Brampton, Ontario
L6T 1C1
Submission Control No.: 264187
_________________________________________________________________________________________
_Taro-Desvenlafaxine (desvenlafaxine succinate monohydrate) Product
Monograph _
_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFOR
M
ATION
.............................................................................
3
SUMMARY PRODUCT INFORMATION
...................................................................................................
3
INDICATIONS AND CLINICAL USE
.........................................................................................................
3
CONTRAINDICATIONS
..............................................................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................................................
4
ADVERSE REACTIONS
............................................................................................................................11
DRUG INTERACTIONS
.............................................................................................................................21
DOSAGE AND ADMINISTRATION
.........................................................................................................24
OVERDOSAGE
...........................................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................................28
STORAGE AND STABILITY
....................................................................................................................31
SPECIAL HANDLING INSTRUCTIONS
.
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